BS EN 60601-1-11:2010 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
BS EN 60601-1-11 constitutes a collateral standard to BS EN 60601-1:2006 Medical electrical equipment. General requirements for basic safety and essential performance.
Medical practice is increasingly using medical electrical equipment and medical electrical systems for monitoring, treatment or diagnosis of patients in the home healthcare environment.
The safety of medical electrical equipment in this uncontrolled environment with regard to the electrical installation and its related safety and protection means is a cause for concern. The potential lack of training of the lay operator and possibly of those supervising the use of the medical electrical equipment or medical electrical system and their level of education need to be addressed in the development of the accompanying documents and in the relevant marking on the equipment itself so that this material can be understood. The ‘instructions for use’ in BS EN 60601-1-11 give special guidance on how this should be addressed.
BS EN 60601-1-11 was developed with contributions from clinicians, engineers and regulators. The terminology, requirements, general recommendations and guidance of this standard are intended to be useful for manufacturers of medical electrical equipment and medical electrical systems and for technical committees responsible for the development of particular standards.
BS EN 60601-1-11 has been prepared under a mandate given to CENELEC by the European
Commission and the European Free Trade Association and within its scope the standard covers all relevant essential requirements as given in Annex I of the EC Directive 93/42/EEC.
Compliance with this standard provides one means of conformity with the specified essential requirements of the Directive concerned.
Other requirements and other EC Directives may be applicable to the products falling within the scope of this standard.
Contents of BS EN 60601-1-11 include:
- Scope, object and related standards - IEC 60601 and particular standards
- Normative references
- Terms and definitions
- General requirements
- Additional requirements for supply mains for ME equipment and ME systems
- Environmental conditions for ME equipment
- Environmental conditions of transport and storage between uses
- Environmental operating conditions
- Environmental shock to transit-operable ME equipment
- General requirements for testing ME equipment
- Classification of ME equipment and ME systems
- ME equipment identification, marking and documents
- Usability of the accompanying documents
- Additional requirements for marking of ip classification
- Accompanying documents
- Contact information
- Lay operator briefing information
- Instructions for use
- Additional requirements for warning and safety notices
- Additional requirements for an electrical power source
- Additional requirements for ME equipment description
- Additional requirements for ME equipment start-up procedure
- Additional requirements for operating instructions
- Additional requirements for ME equipment messages
- Additional requirements for cleaning, disinfection and sterilization
- Additional requirements for maintenance
- Additional requirements for environmental protection
- Additional requirements for ME equipment and ME systems
- Technical description
- Permanently installed class I ME equipment
- Additional requirements for professional hygienic maintenance
- Protection against excessive temperatures and other hazards
- Additional requirements for cleaning, disinfection of ME equipment and ME systems
- Additional requirements for sterilization of ME equipment and ME systems
Additional requirements for ingress of water or particulate matter into ME equipment and ME systems
- Ingress of water or particulate matter into ME equipment
- Ingress of water or particulate matter into ME systems
- Additional requirements for interruption of the power supply/supply mains to ME equipment and ME system
- Accuracy of controls and instruments and protection against hazardous outputs
- Construction of ME equipment
- Additional requirements for mechanical strength
- General requirements for mechanical strength
- Requirements for mechanical strength for non-transit-operable ME equipment
- Requirements for mechanical strength for transit-operable ME equipment
- Additional requirements for an internal electrical power source
- Additional requirements for actuating parts of controls of ME equipment
- Protection against strangulation or asphyxiation.
- Additional requirements for electromagnetic compatibility of ME equipment and ME systems
- Emissions classification
- Protection of the public mains network
- Additional technical description requirements applicable to ME equipment and ME systems
- Additional requirements applicable to ME equipment and ME systems
- Specified for use only in a shielded location
- Additional requirements for electrostatic discharge (ESD) tests
- Additional requirements for alarm systems of ME equipment and ME systems
- Additional requirement for generation of alarm signals
- Additional requirement for alarm signal volume
- General guidance and rationale
- Guide to marking and labelling requirements for ME equipment and ME systems
- Symbols on marking
- Bibliography
- Index of defined terms used in this collateral standard
- Small finger probe
- Mechanical strength test applicability, non-transit-operable
- Mechanical strength test applicability, transit-operable
- Summary by use of home healthcare environment ME equipment
- Enclosure ingress of water and particulate matter requirements
- Qualitative assessment of home healthcare environment ME equipment subjected to shock and vibration
- Marking on the outside of ME equipment, ME systems or their parts
- Accompanying documents, instructions for use
- Accompanying documents, technical description
- General symbols
